THE HOSPITAL FORMULARY

Learning Objectives
At the end of the lecture the students will be able to:
• General principles and guidelines to develop formulary
• Format of hospital formulary
• Preparation of the formulary
• Role of pharmacist in formulary making
• Keeping up to date formulary.
• Define formulary and formulary system
• Describe the potential benefits of formulary.
• Differentiate between formulary and drug list.
• Explain the different types of formularies in detail.
• List down the merits and potential demerits of formulary
The Formulary (ASHP):
• Definition: A formulary is a continually updated list of
medications and related information, representing the
clinical judgment of physicians, pharmacists, and
other experts in the diagnosis, prophylaxis, or
treatment of disease and promotion of health.

• A formulary includes, but is not limited to, a list of

medications and medication-associated products or
devices, medication-use policies, important ancillary
drug information, decision-support tools, and
organizational guidelines.
Formulary System (ASHP):
• A formulary system is the ongoing process through
which a health care organization establishes policies
regarding the use of drugs, therapies, and drug-related
products and identifies those that are most medically
appropriate and cost-effective to best serve the health
interests of a given patient population.

• The formulary system is thus an important tool for

assuring the quality of drug use and controlling its
cost.
Origin:
•The formulary was developed in 1950s as a management tool.
•In the late 1950s, the ASHP minimum standard for pharmacies in
hospitals called for the implementation of a formulary system.
•During the 1960s, ASHP and the American Hospital Association (AHA)
issued joint statements on the legality of formularies.
•The American Medical Association (AMA) and the American
Pharmaceutical (later Pharmacists) Association (APhA) subsequently
joined with ASHP and AHA to revise the statements.
•In 1965, the Joint Commission on the Accreditation of Hospitals,
included an active P&T committee in its accreditation requirements
•ASHP and AMA’s official policy on drug formularies was first published
in 1994 and has since been updated several times.
•Today, formulary systems are considered an essential tool for health
care organizations.
CORE ADVANTAGES OF FORMULARY SYSTEM
POSSIBLE DEMERITS OF
FORMULARY
ESSENTIAL FACTORS FOR THE DRUG SELECTION/
Selection Criteria for New Medicines:
• Country disease patterns
• Efficacy
• Safety
• Quality
• Cost-effectiveness
• Health system personnel
available to manage the
medicine
• Financial resources available
• Patient acceptability
WHO IS RESPONSIBLE FOR
MAKING THE
FORMULARY?
• Hospital pharmacists
• Prescribers /Physician
• Medical professionals
TYPES OF FORMULARIES:
1. NATIONAL FORMULARY:
• It is the compilation of all drugs available in the country.
• It should provide an information on drugs for prescribers in a user friendly form.
•It includes key information on the composition, description, selection,
prescribing, dispensing and administration of medicines.
• Examples of national formularies are:
✔ Australian Pharmaceutical Formulary (APF)
✔ British National Formulary (BNF) and British National Formulary for Children
(BNFC)
✔ Indian National Formulary
✔ Kazakhstan National Formulary
✔ Sri Lankan Formulary
✔ United States National Formulary, later bought out and merged with the
United States Pharmacopeia (USP-NF)

• List of all national formularies can be found at WHO Website:

https://www.who.int/medicines/publications/pharmacopoeia/index-of-
pharmacopoeias_17012018.pdf?ua=1
EXAMPLES OF NATIONAL FORMULARY:
2. LOCAL OR PRIVATE FORMULARY:
• Also known as hospital owned formulary.
• It is the compilation of all drugs available in an institution.
• It contains a restricted number of drugs and may include only
some of the drugs listed in National formulary.
• Advantages of local formulary are: Creates a feeling of a sense
of pride and determination to make the system succeed.
• Contents and information are provided under each monograph
according to the local needs.
• May include sections on related clinical matters.
• May be published in a more convenient size and format.
• Allows possibility of addition or deletion.
EXAMPLE OF LOCAL OR PRIVATE FORMULARY:

https://www.hopkinsmedicine
.org/johns_hopkins_healthca
re/providers_physicians/our_
plans/ehp/pharmacy_formula
ry/index.html
PURCHASED FORMULARY:

A drug monograph service such as the American Hospital Formulary

Service (AHFS), a publication of the American Society of Hospital
Pharmacists (AHSP) can be subscribe for a basis for preparation of
formulary in an institution.
• AHFS was first published in 1959 .
• First publication in 2002, the WHO Model Formulary has
become an source of independent information.
• For each medicine the WHO model Formulary provides information
on use, dosage, adverse effects, contraindications and warnings,
supplemented by guidance on selecting the right medicine for a
range of conditions.
WHO Model Lists of Essential
Medicines
• The WHO Model Lists of Essential Medicines are updated every
two years by the Expert Committee on Selection and Use of
Essential Medicines.
• The first Essential Medicines List was published in 1977, and
the first Essential Medicines List for Children was published in
2007.
• The current versions, updated in July 2023, are the
23rd Essential Medicines List (EML) and the 9th Essential
Medicines List for Children (EMLc).
SPECIALTY FORMULARY:
• A formulary prepared for and provides information
on very particular specialty products is the specialty
formulary.
• Increasing use of enteral nutrition products in
hospitals required such formulary for use of the
medical and dietetic staff.
• The formulary reports product variables such as calories ,
protein contents, fat contents and sources etc.
OBJECTIVES OF A FORMULARY
1. To setSYSTEM:
standards for best practice, promoting high quality,
evidence based prescribing.

2. To ensure rational drug therapy and control drug cost.

3. To precise use by the physician and nursing staff.

4. Provides periodic evaluation and analysis of treatment protocols

and procedures to ensure that they are up-to-date and are
consistent with optimum therapeutics.

5. Provides monitoring, reporting, and analysis of adverse results of

drug therapy (e.g., adverse drug reactions, medication errors) to
continuously improve the quality of care.
PRINCIPLES OR GUIDE LINES TO DEVELOP OR COMPILE A
1.FORMULARY:
Medicines should be selected based on the needs of the
community.
2. Medicines selected for the formulary are “medicines of choice.”
3. The formulary list should have a limited number of medicines;
duplication of agents that have therapeutic equivalence should not
occur.
4. International nonproprietary names (INN) (i.e., generic names)
should be used.
5. Combination (fixed-dose) products should be used only in
specific proven conditions (e.g., to treat tuberculosis).
6. Medicines need to be selected based on proven efficacy, safety,
quality, and cost.
7. Formulary must be reliable with any national or approved
standard treatment guidelines.
8. Medicines should be restricted to appropriate practitioners.
PRINCIPLES OR GUIDE LINES TO DEVELOP OR COMPILE A
FORMULARY:
9. The governing body of the hospital should appoint a pharmacy and
therapeutic committee (PTC) which will prepare the hospital
formulary system.
10. PTC develop policies and procedures - medical staff adopt these
11. The policy and procedures shall give guidance in the appraisal,
selection, procurement, storage, distribution, use, safety
procedures and other matter relating to drug in the hospital and
shall be published in the hospital’s formulary or other media
available to the member of medical team.
12. Prescribers should be strongly encouraged to prescribe drugs by
their nonproprietary names.
13. Medical & nursing staffs are informed about the changes in the HF
system.
FACTORS CONSIDERED BY P&TC TO DEVELOP OR COMPILE A
FORMULARY:
• Medical and clinical literature including clinical trials and treatment
guidelines, comparative effectiveness reports, pharmacoeconomic
studies and outcomes data;
• FDA-approved prescribing information and related FDA information
including safety data;
• Relevant information on use of medications by patients and
experience with specific medications;
• Current therapeutic use and access guidelines and the need for
revised or new guidelines;
• Economic data, such as total health care costs, including drug costs;
• Drug and other health care cost data (not all P&T committees review
drug specific economic data); and
• Health care provider recommendations.
FORMULARY MANAGEMENT SYSTEM:
1. Production
2. Distribution
3. Updating
1. Production
• A technical ,complex and time consuming task.
• A Pharmacist should be included as an obvious member.
• Production involves the gathering of data on which the drug selection has to be
made.
• A complete new formulary can be prepared from start or can be modified from
existing formulary.
• Once the selection is made , the format of the material and the design of the final
document are to be considered.
• American hospital formulary, British National formulary, WHO Model formulary
are the examples which can be used as a guidelines for the production of formulary.
FORMULARY MANAGEMENT SYSTEM:
2. Distribution
• On the completion the copies are distributed among all the prescribers , nurses ,
medical staff.
• It should be placed at each patient care unit, each pharmacy division and HODs
should receive a copy of it.
• The necessary step is to ensure that the nursing and other medical staff are familiar
with the use of formulary.

3. Updating:
Formulary is to be revised continuously on six months, biennial or annual basis. This is
required due to:
•Introduction of new drugs.
•Removal of existing drugs from market place
•Change in hospital policies and procedures
•Evidence of efficacy of existing drugs in novel indications
•Changing data on adverse drug reaction profiles
•Demands for inclusion / exclusion of new existing drugs from the formulary
FORMULARY CONTENT &
ORGANIZATION:
Primary Objectives:
The Formulary should consist of 03 main parts:
a) Information on hospital policies & procedures concerning drugs.
b) Drug products listing
c) Special information about drugs
FORMULARY CONTENT &
a) ORGANIZATION:
Information on hospital policies & procedures:

1. Description of PTC
2. Hospital regulations about prescribing, dispensing &
administration of drug, rules for Medical Reps, emergency drug
products, Writing of drug orders and prescriptions, Controlled
substances considerations, Automatic stop orders e.t.c
3. Pharmacy operating procedures
4. Information on using formulary
5. Formulary policies and procedures including restrictions on drug
use (if any) and procedures for requesting addition of drug into
the formulary
FORMULARY CONTENT &
b)ORGANIZATION:
Drug products listing
This section is the core of the formulary .
1. The formulary entries can be arranged in several ways:
✔ 1. Alphabetically by generic name
✔ 2. Alphabetically with therapeutic class
✔ 3. A combination of the two systems whereby the bulk of the drug
products are contained (alphabetically) in a general section
supplemented by several special sections
2.Type of information: Dosage form, strength, packaging Active
ingredients Adult/pediatric dose Route of administration Cost
3.Indexes to the drug products listing: Generic name/brand name
Therapeutic /Pharmacological index
FORMULARY CONTENT &
b)ORGANIZATION:
Special information

✔ Nutritional product list.

✔ Tables of equivalent dosages.
✔ Hospital approved abbreviations.
✔ Calculating pediatric dosages.
✔ Sugar free drug product list.
✔ List of contents of emergency carts
✔ Metric conversions scales and tables.
✔ Drug –drug interactions.
✔ Drug incompatibilities.
✔ Poison control information
STEP INVOLVE IN PREPARATION OF THE FORMULARY:
1. Identify the most common diseases being treated in the hospital by
consulting all medical departments.

2. For each disease, an appropriate first choice of treatment should be

identified using standard treatment guidelines.

3. An expert committee can be brought together to identify the

appropriate treatment for each of the common health problems.

4. The alternative method is reviewing the WHO model list of

essential medicines may also be used as a starting point.
STEP INVOLVE IN PREPARATION OF THE FORMULARY:
5. A draft of the list must be prepared and must be given to
each department to comment on the list.

6. P&TC must deliberate on their comments and provide feedback.

7. All information should be discussed with evidence based

reviews where possible.

8. After the preparation of final list, monographs for each drug

should be prepared and it should contain unbiased
information
INFORMATION AVAILABLE IN FORMULARY MANUAL RELATED TO DRUG
Miscellaneous information—
Basic information— 1. Supplementary information for medicines
1. Formulary list or essential medicines { Price
list—both alphabetical and { Regulatory category
therapeutic category lists { Storage guidelines
2. Brief information about each medicine { Patient counseling information
(i.e., a medicine monograph) { Labeling information
{ Generic name { Brand names and synonyms
{ Dosage and strengths 2. Prescribing and dispensing guidelines
{ Indications 3. Treatment protocols
{ Contraindications { IV medicine administration guidelines
{ Precautions { Medicines used in pregnancy and lactation
{ Side effects { Medicines used in renal failure
{ Dosage schedule { Poison guidelines
{ Instructions and warnings { Prescribing for the elderly
{ Medicine, food, lab interactions • Other components
{ ADR form
{ Formulary request form
{ Abbreviations within the health care
• The drug evaluation monograph provides a structured method
to review the major features of a drug product.
• Once a monograph is prepared, it can easily be used as a
structured template or overview of a drug product.
• That allows for easy comparison or contrast to other products
that may be used for the same indication or that are in the same
product class.
ESSENTIAL INFORMATION FOR DRUG
✔ MONOGRAPH?
Brand and generic names
✔ FDA approval information
✔ Pharmacology and mechanism of action
✔ FDA-approved indications
✔ Potential non-FDA-approved (off-label) uses
✔ Dosage forms and storage
✔ Recommended dosage regimens
✔ Pharmacokinetic considerations
✔ Use in special populations (e.g., children, elderly, patients with renal or liver failure)
✔ Pregnancy category and use during breast-feeding
✔ Comparisons of the drug’s efficacy, safety, convenience, and costs with those of therapeutic alternatives
✔ (with evidence tables when feasible)
✔ If information on comparative efficacy is minimal or lacking, data on absolute efficacy (i.e., efficacy
versus placebo)
✔ Clinical trial analysis
✔ Medication safety assessment and recommendations
✔ (adverse drug reactions; drug–drug and drug–food interactions; specific therapy monitoring
requirements;
✔ unusual administration, storage, or stability issues; and potential for medication errors, such as look-
alike or sound-alike issues)
✔ Financial analysis
✔ Formulary status recommend
Resources used for Drug Monograph

The following may be consulted in developinga drug

monograph:
1. AHFS Drug information
2. Thomson Micromedex Healthcare Series
3. Lexi-Comp’s Drug information handbook
4. Pharmaguide
5. BNF
Drug Monograph
Template
Drug Monograph
Template
Drug Monograph
Template
FORMAT AND APPEARANCE OF THE FORMULARY:
A typical composition in the following manner.
1. Title page.
2. Names and titles of the member of P&TC
3. Table of contents.
4. Information on hospital policies and procedure concerning drugs.
5. Size.
6. Format
• Loose leaf or Bound
• Printed
7. Indexing and assigning categories
• General index
• Pharmacological index
TECHNIQUES TO ENHANCE FORMAT AND APPEARANCE:
• Use of different colors to differentiate different categories of drug.
• Attractive designing of the cover page
• It should be visually pleasing, easy to read and have a
professional appearance
• Use of different color papers for each section of the formulary.
• Making the formulary pocket size ( approx. 4inch x 7 inch).
• Printing the generic name heading of each drug entry in
boldface type
PUBLICATION:
• The formulary is a professional publication and should reflect the high
ethical standards of the hospital and its staff.
• A printed hospital formulary is obviously more visual in
appearance and easier to read.
• Utilization of computer may lower the cost of producing formulary.
CATEGORIZING AND INDEXING:

• An effective categorizing and proper indexing of the information on

the formulary is necessary for its quick research.

• It requires pharmacist expended efforts.

• Most formularies have a general index located at the end of the text.

• This is usually alphabetical by generic name and is cross linked with

brand name of the drugs used in the text portion of the formulary.
Steps involve in Keeping Formulary up-to-date or Maintenance of Form

1.Drugs listed in the Hospital Formulary shall be reviewed periodically by the

P&&TC in order to add new drug or delete adrug from the hospital formulary based
upon Selection Criteria for New Medicines.

2.A request for addition or deletion to the formulary shall be submitted to the
Pharmacy Service by filling "Request for Addition/Deletion” Form having REASON
FOR PREFERING NEW DRUG OVER EXISTING DRUG.

3.Pharmacist is responsible for preparing the drug evaluation monograph ( DEM) for
the drugs to be included in the formulary using established “Selection Criteria for
New Medicines”.

4. Medicine information obtained from resources are credible and unbiased.

5. Formulary recommendations are developed.
6.Monograph will be presented to P & TC for review and if approved, the drug
will be added in the formulary
Steps involve in Keeping Formulary up-to-date or Maintenance of
Formulary
7.P&TC shall allow addition of drugs to the formulary where justification is
provided for:
✔ Superiority of the drug
✔ Effectiveness of a new drug
✔ Combination products may be considered when a therapeutic or substantial cost
advantage
✔ Include a drug whose formula is known and its therapeutic value is established.

8.The individual who initiated the "Formulary Change Request" shall be informed
about the committee meeting and may be invited.

9.All drugs added to the formulary shall be listed under a non-proprietary (generic)
name.
Steps involve in Keeping Formulary up-to-date or Maintenance of
Formulary

10.DELETION OF DRUGS: At suitable intervals, the pharmacy will report

to the P&TC, about the drugs which are rarely used for a long period
of time or Drugs that are discontinued worldwide or are banned,
or Evidence of serious adverse effects or manufacturer ceases
its production, shall be deleted from the hospital formulary.

11.Information regarding addition or deletion of drug shall be

disseminated to all the healthcare professionals in the hospital.
Keeping up-to-date formulary:
Non Formulary Drug :
✓ Drugs which are not currently approved by the P&T Committee for
use at hospitals are termed as non formulary.
✓ Only those drugs which are listed in the formulary of the will be
stocked in the pharmacy and accordingly prescribed by the medical
staff. However, in special clinical situations an attending physician may
request procurement of a specific drug if, in his opinion:
• None of the currently available formulary products meet the
therapeutic needs of the patient
• All acceptable therapeutic alternatives listed in the formulary have
been tried and failed
• Non formulary product is superior to the available alternatives
• Examples include advanced cancer therapies, biologic treatments
for autoimmune conditions, and novel diabetes medications.
Procedure for Requesting Non Formulary Drug
1. Submit supporting literature to Section Head for approval. Once
signed, Form and literature are sent to the Head of Pharmacy for
approval.
2. The Head of Pharmacy may consult experts within the hospital or
the P&T Committee Chair for their opinion of the request.
3. If the Head of Pharmacy approves the request, he will then arrange
procurement of the medication. The time required to make this
drug available depends on its local availability.
4. A non formulary drug is only to be used by the requesting
physician for a single patient. Proper documentation of use will be
maintained by the pharmacy.
5. The requesting physician is required to complete form follow up
letter describing the treatment outcome with non formulary drug.
6. A summary of all non formulary drug requests will be presented
periodically to the P&T Committee for review.
Role of P&TC IN HOSPITAL
FORMULARY:
1. Preparation of Hospital Formulary (Evaluates, appraises and selects
dosage forms, those that are considered most useful to and
effective patient care).
2. Assistance in policy formation
3. Decision for the format of formulary
4. Selection of formulary
5. Selection of Information to be proved
ROLE OF PHARMACIST IN HOSPITAL
• Establish P&T committee meeting agenda.
FORMULARY:
• Reporting Adverse drug reaction data of drug.

• Prepare Drug Evaluation Monograph (DEM).

• Conduct Drug Utilization Review(DUR) and Analyze data

• Conduct Annual formulary review Process.

• Record and archive P&T committee actions.

• Communicate P&T committee decisions to other health care

professionals such as pharmacy staff, medical staff, and patient
care staff.
Thank
You
Reference:
• Hospital Pharmacy Sixth , EditionWilliam E. Hassan, Page # 124-153
• ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System
• https://www.who.int/medicines/technical_briefing/tbs/02-PG_Formulary-Management_final-08.pdf
• Ramesh K. Goyal, R.K. Parikh, Text book of Hospital Pharmacy, 12th edition, pg.no:40-53.
• Anees A. Siddiqui, Imran Parvez, Seemi Siddiqui Text book of Hospital and clinical pharmacy, pg.no:28-37.
• Revikumar K G , miglani B D, Textbook of pharmacy practice, career publications, pg no;82-94 25